Devices, systems, and methods to precondition, arterialize, and/or occlude a mammalian luminal organ

Abstract

Devices, systems, and methods to precondition, arterialize, and/or occlude a mammalian luminal organ. In an exemplary embodiment of a device for preconditioning, arterializing, and/or occluding a mammalian luminal organ of the present disclosure, the device comprises a frame comprising a plurality of struts, wherein at least one strut of the plurality of struts forms a local general perimeter or boundary of the device, and an expandable occluder coupled to the frame and comprising a membrane or other expandable material that can generally expand and/or unfold as device shifts from a first configuration to a second configuration.

1 . A device for preconditioning, arterializing, and/or occluding a mammalian luminal organ, comprising:
 a frame comprising a plurality of struts, wherein the plurality of struts form a local general perimeter or boundary of the device, and wherein the plurality of struts include at least a first strut, a second strut, and a third strut, wherein along a long axis of the frame a first space between the first strut and the second strut is different than a second space between the second strut and the third strut, the first space measured from a center or mid-line of the first strut and the second strut, and the second space measured from a center or mid-line of the second strut and the third strut; and   an expandable occluder coupled to the frame and comprising a membrane or other expandable material that can generally expand and/or unfold as device shifts from a first configuration to a second configuration;   wherein the expandable occluder spans an entire cross-sectional area of the device at a location of the expandable occluder; and   wherein the expandable occluder has one or more apertures defined therethrough, the one or more apertures configured to reduce an extent of stenosis within a luminal organ caused by the device by allowing blood to flow through the one or more apertures when the device is positioned within the luminal organ.   
     
     
         2 . The device of  claim 1 , wherein the device is configured so that when cells or other particulate matter contact the expandable occluder at or near the one or more apertures, the expandable occluder causes a gradual increase in the extent of stenosis over time due to the cells or other particulate matter aggregating within the one or more apertures until the extent of stenosis is a complete stenosis. 
     
     
         3 . The device of  claim 1 , wherein the first configuration is a generally compressed configuration, and wherein the second configuration is a generally expanded or deployed configuration. 
     
     
         4 . The device of  claim 1 , wherein the expandable occluder is located at or near a distal end of the device. 
     
     
         5 . The device of  claim 1 , wherein the expandable occluder is located at a relative center/middle of the device. 
     
     
         6 . The device of  claim 1 , wherein the expandable occluder comprises a biologically-compatible material comprising polytetrafluoroethylene (PTFE). 
     
     
         7 . The device of  claim 1 , wherein the expandable occluder comprises a biological material. 
     
     
         8 . The device of  claim 1 , wherein the plurality of struts further comprises at least one lateral strut. 
     
     
         9 . The device of  claim 1 , wherein the expandable occluder is coupled to the frame at a most distal end of a plurality of perimeter struts. 
     
     
         10 . The device of  claim 1 , wherein at least part of the device tapers from a first end to an opposite second end. 
     
     
         11 . A method of using a device, comprising the steps of:
 inserting a device of the present disclosure within a non-arterial luminal organ, the device comprising:
 a frame comprising a plurality of struts, wherein the plurality of struts form a local general perimeter or boundary of the device, and wherein the plurality of struts include at least a first strut, a second strut, and a third strut, wherein along a long axis of the frame a first space between the first strut and the second strut is different than a second space between the second strut and the third strut, the first space measured from a center or mid-line of the first strut and the second strut, and the second space measured from a center or mid-line of the second strut and the third strut; and 
 an expandable occluder coupled to the frame and comprising a membrane or other expandable material that can generally expand and/or unfold as device shifts from a first, collapsed configuration to a second, expanded configuration; 
 wherein the expandable occluder spans an entire cross-sectional area of the device at a location of the expandable occluder; and 
 wherein the expandable occluder has one or more apertures defined therethrough, the one or more apertures configured to reduce an extent of stenosis within the non-arterial luminal organ caused by the device by allowing blood to flow through the one or more apertures when the device is positioned within the non-arterial luminal organ; and 
   expanding the device from a first, collapsed configuration to a second, expanded configuration to anchor the device within the non-arterial luminal organ; and   wherein the device, when in the second, expanded configuration, is operable to block bodily fluid therethrough at the location of the expandable occluder.   
     
     
         12 . The method of  claim 11 , wherein the device, when expanded and anchored in a vein, facilitates preconditioning of the vein prior to arterialization. 
     
     
         13 . The method of  claim 11 , wherein when the device is expanded and anchored in a vein at a bifurcation having a first side branch and a second side branch, blood can flow through the first side branch but not the second side branch. 
     
     
         14 . The method of  claim 11 , wherein the device, when expanded and anchored in the non-arterial luminal organ, causes a localized stenosis at or near the expandable occluder. 
     
     
         15 . The method of  claim 11 , further comprising the step of:
 performing a medical procedure after the device is anchored within the non-arterial luminal organ.   
     
     
         16 . The method of  claim 11 , further comprising at least one lateral strut, the at least one lateral strut connected to at least two of the plurality of perimeter struts, and wherein the step of inserting is performed to insert the device within a non-arterial luminal organ at a bifurcation so that the bifurcation is located at the at least one lateral strut. 
     
     
         17 . The method of  claim 11 , wherein the device is configured so that when cells or other particulate matter contact the expandable occluder at or near the one or more apertures, the expandable occluder causes a gradual increase in the extent of stenosis over time due to the cells or other particulate matter aggregating within the one or more apertures until the extent of stenosis is a complete stenosis, and wherein the step of expanding is performed to expand the occluder to facilitate the gradual increase in the extent of stenosis over time. 
     
     
         18 . A device for preconditioning, arterializing, and/or occluding a mammalian luminal organ, comprising:
 a frame comprising a plurality of struts, wherein the plurality of struts form a local general perimeter or boundary of the device, and wherein the plurality of struts include at least a first perimeter strut, a second perimeter strut, and a third perimeter strut, wherein the first perimeter strut is adjacent the second perimeter strut and the second perimeter strut is adjacent the third perimeter strut, wherein along a long axis of the frame a first gap exists between the first perimeter strut and the second perimeter strut and a second gap exists between the second perimeter strut and the third perimeter strut, wherein the first gap is larger than the second gap, and wherein the plurality of struts further comprises at least one lateral strut in between the first, second, and third perimeter struts, the first gap measured from a center or mid-line of the first perimeter strut and the second perimeter strut, and the second gap measured from a center or mid-line of the second perimeter strut and the third perimeter strut; and
 an expandable occluder coupled to the frame and comprising a membrane or other expandable material that can generally expand and/or unfold as device shifts from a first configuration to a second configuration; 
 wherein the first configuration is a generally compressed configuration, and wherein the second configuration is a generally expanded or deployed configuration; and 
 wherein the first configuration allows the device to be delivered intravascularly within a patient; 
 wherein the expandable occluder spans an entire cross-sectional area of the device at a location of the expandable occluder; and 
 wherein the expandable occluder has one or more apertures defined therethrough, the one or more apertures configured to reduce an extent of stenosis within a luminal organ caused by the device by allowing blood to flow through the one or more apertures when the device is positioned within the luminal organ. 
   
     
     
         19 . The device of  claim 18 , wherein the expandable occluder comprises a biological material selected from the group consisting of visceral pleura and lung ligament tissue. 
     
     
         20 . The device of  claim 1 , wherein the device is configured so that when cells or other particulate matter contact the expandable occluder at or near the one or more apertures, the expandable occluder causes a gradual increase in the extent of stenosis over time due to the cells or other particulate matter aggregating within the one or more apertures until the extent of stenosis is a complete stenosis.